DepressionProjectTECHNCT01912729

Technology Assisted Programs That Promote Mental Health for Teenagers

A study testing Networked Peer Support with Peer Guide and Networked Peer Support with Clinician Coach in people with Depression, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Networked Peer Support with Peer Guide and Networked Peer Support with Clinician Coach
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS).
Is familiar with the use of computers and the Internet, as well as mobile phones
Is able to speak and read English
Is between 14-19 years of age

Who cannot join

Is currently taking an antidepressant medication or has taken one in the previous 3 months
Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis.
Is severely suicidal (has ideation, plan, and intent in the past 12 months) .

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression

The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

Read the detailed description

Conditions: Depression
Being tested: Networked Peer Support with Peer Guide, Networked Peer Support with Clinician Coach
Keywords: Depression prevention, Technology Assisted, Adolescents, Peer networked
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Networked Peer Support with Peer GuideBehavioural
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
Networked Peer Support with Clinician CoachBehavioural
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.

Study groups in NCT01912729
Study group	Role	What they receive
Networked Peer Support with Peer Guide	Experimental	Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach. Receives: Behavioral: Networked Peer Support with Peer Guide
Networked Peer Support with Clinician Coach	Experimental	Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach. Receives: Behavioral: Networked Peer Support with Clinician Coach
Wait List Control	No intervention	Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Program Logins Per Participant by Week.
Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
Measured: Weeks 1-8
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree.
Lund, A.M., 2001. Measuring Usability with the USE Questionnaire.
Measured: Week 4 and Week 8
SUS (System Usability Scale) Questionnaire
The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Measured: Week 4 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jul 2016

First posted31 Jul 2013 (estimated)
Study startJan 2016
Primary completionJun 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01912729
Sponsor's protocol ID: P20MH090318 STU00056069-FTPT
Other IDs: P20MH090318
Acronym: ProjectTECH
Status last verified: Nov 2018
First submitted: 29 Jul 2013
Last updated: 13 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression
ClinicalTrials.gov ID: NCT01912729
Acronym / sponsor ID: ProjectTECH / P20MH090318 STU00056069-FTPT
Conditions: Depression
Keywords: Depression prevention, Technology Assisted, Adolescents, Peer networked
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Jan 2016
Primary completion: Jun 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 31 Jul 2013 (estimated)
Results: Posted 21 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Networked Peer Support with Peer Guide	Experimental	Behavioral: Networked Peer Support with Peer GuideParticipants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Networked Peer Support with Clinician Coach	Experimental	Behavioral: Networked Peer Support with Clinician CoachParticipants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Wait List Control	No intervention	–Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.

Who may qualify

Ages: 14 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS).
Is familiar with the use of computers and the Internet, as well as mobile phones
Is able to speak and read English
Is between 14-19 years of age

Key exclusion criteria (4 listed)

Is currently taking an antidepressant medication or has taken one in the previous 3 months
Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis.
Is severely suicidal (has ideation, plan, and intent in the past 12 months) .

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Networked Peer Support with Peer GuideParticipants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.	Behavioural	Networked Peer Support with Peer Guide
Networked Peer Support with Clinician CoachParticipants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.	Behavioural	Networked Peer Support with Clinician Coach

Primary outcome

Program Logins Per Participant by Week.
Time frame: Weeks 1-8
Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Time frame: Week 4 and Week 8
A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree. Lund, A.M., 2001. Measuring Usability with the USE Questionnaire.
SUS (System Usability Scale) Questionnaire
Time frame: Week 4 and Week 8
The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.

Results and safety

Results posted to the registry on 21 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Networked Peer Support With Peer Guide	20	20
Networked Peer Support With Clinician Coach	20	19

Primary outcome: Program Logins Per Participant by Week.

Time frame: Weeks 1-8. Mean (Standard Deviation). Unit: number of program logins

Measure	Arm 1 - Networked Peer Support With Peer Guide n = 20	Arm 2 - Networked Peer Support With Clinician Coach n = 19
Week 1	9.15 (4.12)	8.17 (4.02)
Week 2	3.6 (2.91)	6.06 (6.48)
Week 3	2.8 (2.12)	3.39 (2.62)
Week 4	2.8 (2.44)	2.44 (2.55)
Week 5	2.6 (2.01)	2.28 (1.87)
Week 6	2.05 (1.9)	2.33 (2.57)
Week 7	1.7 (1.75)	1.11 (1.84)
Week 8	1.95 (2.31)	1.22 (1.4)

Primary outcome: USE (Usefulness, Satisfaction and Ease of Use) Questionnaire

Time frame: Week 4 and Week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1 - Networked Peer Support With Peer Guide n = 20	Arm 2 - Networked Peer Support With Clinician Coach n = 19
Usefulness at Week 4	4.04 (1.73)	4.4 (1.01)
Usefulness at Week 8	4.36 (1.62)	4.53 (0.97)
Ease of Learning at Week 4	5.21 (2.07)	5.55 (1.4)
Ease of Learning at Week 8	5.73 (1.25)	5.38 (1.53)
Ease of Use at Week 4	4.79 (1.95)	5.15 (1.28)
Ease of Use at Week 8	4.96 (1.27)	5.03 (1.44)
Satisfaction at Week 4	4.18 (2.04)	4.2 (1.44)
Satisfaction at Week 8	4.23 (2.01)	4.29 (1.27)

Primary outcome: SUS (System Usability Scale) Questionnaire

Time frame: Week 4 and Week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1 - Networked Peer Support With Peer Guide n = 20	Arm 2 - Networked Peer Support With Clinician Coach n = 19
SUS score at Week 4	61.53 (15.1)	71.91 (18.74)
SUS score at Week 8	66.72 (14.82)	69.53 (21.16)

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 - Networked Peer Support With Peer Guide	0 of 20 (0%)	0 of 20 (0%)	Not reported
Arm 2 - Networked Peer Support With Clinician Coach	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David C Mohr, Ph.D principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Networked Peer Support with Peer Guide and Networked Peer Support with Clinician Coach in people with Depression, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program Logins Per Participant by Week. (time frame: Weeks 1-8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01912729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.